Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer Post Neoadjuvant Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Participation Compliance
研究概览
简要总结
The primary goals of this trial will be to determine the safety and immune activity of HER-2 pulsed DC1 vaccine in patients with high risk HER-2pos breast cancer with residual disease post neoadjuvant therapy. Investigators will also explore the possibility of determining whether circulating tumor cells can be used as surrogate to assess response to vaccination.
详细描述
Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prevention of breast cancer in high risk settings. There is a need to determine whether this ICAIT DC1 can activate CD4 and CD8 T cells prior to or in combination with chemotherapy with or without added trastuzumab.
This study began at the Abramson Cancer Center of the University of Pennsylvania and will be continued at H. Lee Moffitt Cancer Center and Research Institute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years.
- •HER-2 expressing stage I - III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy.
- •Women of childbearing age with a negative pregnancy serum test documented prior to enrollment.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or
- •Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
- •Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
排除标准
- •Pregnant or lactating.
- •Positive for HIV or hepatitis C at baseline by self report.
- •Potential participants with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec.
- •Potential participants with MUGA < 50% EF.
- •Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
结局指标
主要结局
Participation Compliance
时间窗: Up to 18 months
Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (6 weekly vaccinations). Data collection will include rate of successful completion and occurrence rate for each reason stated for non-completion.
Occurrence of Treatment Related Adverse Events
时间窗: Up to 18 months
Number of participants with treatment related adverse events, per event category.
次要结局
- Anti-HER2 Immunity(Up to 5 years follow-up)
- Immunogenicity(Up to 5 years follow-up)